- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance of validated...capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …transfer traceability from Primary Standards to Laboratory Working StandardsSupport validation and production engineers in development of metrological specifications ... for new equipmentDevelop control charts and statistical process controls for calibration standards and resultsAssist in the implementation and maintenance of ISO 17025 (if applicable) Quality Management SystemComplete documentation and reports of all… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …manufacturing equipment in accordance with site Change Control and Validation requirementsPerform investigation of manufacturing eventsPerform process & engineering ... processing techniques preferredKnowledge of pharmaceutical product development, manufacturing processes, validation , cGMP's and FDA regulations for the Pharmaceutical IndustryProficiency… more
